Kornimate/medical-research-clean huggingface dataset:
intracervical block versus placebo to assess pain control during hysterosalpingogram

Conditions: Infertility

Summary: the purpose of this study is to compare the efficacy of 1% lidocaine intracervical block to placebo for pain control during the performance of a hysterosalpingogram (hsg). we hypothesized that an intracervical block would decrease pain during a hysterosalpingogram.

the hysterosalpingogram (hsg) is an integral part of the evaluation for anatomic etiologies of female infertility. the majority of women regard a hysterosalpingogram as acutely painful since it involves placement of a cervical tenaculum, traction on the cervix, and instillation of dye through a cervical cannula. different techniques have been employed to attempt to make the procedure less painful, including use of balloon catheters rather than cannulas; however, this has not been shown to be uniformly effective. previous studies have shown a reduction in overall pain during hsg after pre-medication with oral non-steroidal anti-inflammatory drugs. benzocaine gel (20%) applied to the cervix has also been shown to reduce pain. conversely, a study of pre-medication with paracetamol (acetaminophen) showed no statistical improvement in pain perception. additionally, transcervical intrauterine instillation of lidocaine has been shown in randomized studies to not improve pain scores and may actually increase pain after the procedure is complete a medline literature search of papers written in english from january 1966 to august 2005, using the keywords "hysterosalpingogram," "analgesia", "paracervical," and "intracervical" did not reveal any prior studies on the use of an intracervical block prior to hysterosalpingography. a paracervical block has been shown to decrease pain with therapeutic abortions, endometrial biopsy, and office hysteroscopy (7, 8). we hypothesized that an intracervical block would also decrease pain during a hysterosalpingogram. a three armed, randomized controlled trial comparing pain control after a 1% lidocaine intracervical block, saline injection or no injection in patients undergoing hysterosalpingogram was performed.

Eligibility criteria:
inclusion criteria: * all patients without a known cause for their infertility who were undergoing a hysterosalpingogram were eligible for enrollment. * all subjects were 18 to 40 years of age and married. exclusion criteria: * included a history of any allergies to local anesthetics, radio-opaque dye or to anti-inflammatory medications.

Keywords: hysterosalpingogram intracervical local anesthesia pain perception visual analogue scale
a phase ii clinical study of the efficacy and safety of hrs9950 tablets in chronic hepatitis b patients who are virologically suppressed on nucleoside or nucleotide analogues (nas)

Conditions: Chronic Hepatitis B

Summary: to evaluate the efficacy and safety of hrs9950 tablets in chronic hepatitis b patients who are virologically suppressed on nucleoside or nucleotide analogues (nas).


Eligibility criteria:
inclusion criteria: 1. meet the body mass index standard among 18.0 to 30 kg/m2;； 2. chronic hepatitis b defined as hbv infection documented for at least 6 months prior to screening; 3. virologically suppressed on nucleoside or nucleotide analogues treatment with hbv dna below the lower limit of quantitation; 4. on commercially available nas monotherapy for at least 24 weeks before randomization, and the dosing regimen remained unchanged for at least 12 weeks before randomization; 5. need to take effective contraceptive measures； 6. volunteer to sign an informed consent. exclusion criteria: 1. history of cirrhosis or clinical evidence of hepatic decompensation, confirmed or suspected liver cancer, with other liver diseases other than chronic hepatitis b that may affect the evaluation of the study; 2. with autoimmune disease; 3. with poorly-controlled diabetes, thyroid disease requiring clinical intervention, clinically significant thyroid dysfunction, neurological or psychiatric disorder, severe lung disease, chronic renal disease or retinopathy; 4. history of solid organ transplantation or hematopoietic stem cell transplantation; 5. poorly-controlled hypertension, clinically significant and unstable or uncontrolled severe cardiovascular and cerebrovascular diseases; 6. malignant tumors were diagnosed within 5 years prior to randomization； 7. infection requiring intervention within 4 weeks prior to randomization; 8. major trauma or major surgery within the 12 weeks prior to randomization, or surgical plans or other treatment during the study period which the investigators determined may influence the evaluation of the study results; 9. laboratory tests during the screening period were obviously abnormal; 10. prolonged ecg qtc interval (male \> 450ms, female \> 470ms) or other clinically significant abnormal results that may pose significant safety risks to subjects during the screening period; 11. history of drug use, alcohol or drug abuse in the 12 months prior to randomization; 12. participated in clinical study of other drugs (received experimental drugs); 13. pregnant or nursing women; 14. allergic to a drug ingredient or component; 15. other reasons for ineligibility as judged by the investigators.
the evaluation of safety, tolerability and pharmacokinetics of stroke targeting drug in healthy volunteers

Conditions: Stroke

Summary: the purpose of this study in to evaluate safety, tolerability, pharmacokinetics of jpi-289 in healthy male subjects.

tpa treatment should be used within 3 hours after stroke onset for treating efficacy, but jpi-289 treatment(parp-1 inhibitor) showed treating efficacy more than 10 hours after stroke onset. parp-1 inhibitor add-on therapy of tpa will be very useful to prevent social, economic loss from physical, and mental disable by stroke. this clinical trial progresses to explore safety, tolerability, pharmacokinetic/pharmacodynamic properties of jpi-289 by single dose escalation(7cohort). investigational product medication of each level within 4 weeks evaluate safety and tolerability of patient through data safety monitoring board(dsmb) which is composed of more than 3 experts except principal investigator until the last visit. in each level 6 patients for investigational product and 2 patients for placebo will be allocated respectively in double blind manner.

Eligibility criteria:
inclusion criteria: * 19\~55 years healthy male * bmi measurement 20kg/m²\~27kg/m² * 90 ≤ sbp\<140(mmhg) 60 ≤ dbp\<100(mmhg) 45 ≤ pulse rate\<100(bpm) * signed the informed consent from to participate voluntarily and to comply with the trial requirements * for a follow-up visit and during the study period, blood samples and availability exclusion criteria: * history of clinically significant hepatic, gastrointestinal, pulmonary, musculoskeletal, endocrine, psychiatric, hematooncologic, cardiovascular (specially asthma, obstructive pulmonary disease, peptic ulcer) * history of skin disease of graft affecting absorption of the drug * history of drug abuse * positive urine drug screening * administrated investigational product in a previous clinical trial within 60 days of the screening test * donated blood within 60 days prior to screening test

Keywords: parp-1 inhibitor
reducing driving offenses of adolescent drinkers

Conditions: Alcohol Consumption

Summary: to determine the effectiveness of four group session of motivational counseling plus six hours of direct observations of the emergency department trauma services in comparison to four group session and six hours of community volunteering and also in comparison to four hours of education and 16 hours of community volunteering in reducing alcohol use and high risk driving behaviors and offenses among court referred 16-20 year old drivers.


Eligibility criteria:
age 16-20 years: * court referral for driving conviction and/or possession of alcohol * offense committed in rhode island * can speak english exclusion criteria: * age over 20 years * not english speaking * not referred by courts

Keywords: behavioral research motivational counseling group counseling motivational interviewing vicarious learning risky alcohol use recidivism motor vehicles crime
cardiometabolic risk of obese subjects: cross-sectional study

Conditions: Obesity and Obesity-related Medical Conditions; Cardiovascular Risk; Genetics

Summary: experimental study with analysis on tissues. this study aims to study cardiometabolic risk from a genetic, clinical, instrumental and laboratory point of view in a population of subjects with obesity.

compared to normal clinical practice, if you decide to participate in the study you will be asked to: 1. allow the collection of an additional study-specific amount of blood as part of a blood sample already provided for by clinical practice during the dietetic visit; the sample will be used to perform the genetic and laboratory analyses required by the study. 2. undergo an additional study-specific visit within one month of the dietetic visit. will be subjected to the measurement of the degree of vascular aging and the evaluation of the health of his/her arteries, through non-invasive examinations.

Eligibility criteria:
inclusion criteria: * • age \> 18 years * bmi \> 30 kg/m2 * in primary prevention for cardiovascular disease * ability to communicate, make themselves understood and adhere to study-specific procedures * willingness to participate in the study and obtain informed consent exclusion criteria: * patients already enrolled by the research units involved in the enrolment * glycated hemoglobin level \> 55 mmol/l * patients suffering from obesity secondary to endocrinological diseases or iatrogenic causes * patients with heterozygous familial hypercholesterolemia (dutch lipid score - dls\>8) * patients suffering from hypercholesterolemia secondary to lipid or iatrogenic extra-metabolic pathologies * patients suffering from systemic inflammatory or oncological diseases * patients on active treatment with glp-1 analogues * pregnancy and breastfeeding * any medical or surgical condition that makes the patient's adherence to the study protocol complex or inconsistent.
kono-s anastomosis compared to conventional ileocolonic anastomosis to reduce recurrence in crohn's disease

Conditions: Crohn Disease

Summary: crohn's disease (cd) is a chronic inflammatory bowel disease (ibd) currently affecting one person in a thousand in france. it can lead to numerous digestive complications such as fistulas, abscesses or stenosis. despite numerous therapeutic advances, the rate of patients requiring surgery remains very high, with approximately 50% requiring at least one surgical intervention at 10 years after disease diagnosis. however, surgical treatment is not curative, the postoperative recurrence rate being very high, from 65 to-90% endoscopic recurrence at 1 year. the ileocolonic anastomosis is the main site of postoperative recurrence currently defined by a rutgeerts score (≥i2) 6 months after surgery. in 2003, kono et al. described a new operative technique that could reduce the rate of post-operative recurrence: a termino-terminal ileocolonic anastomosis, anti-mesenteric, with a supporting column to prevent distortion and anastomotic stenosis (kono-s anastomosis). the study showed no decrease in endoscopic recurrence rate at 1 year (83% vs 79%), but a significant decrease in surgical recurrence rate at 5 years (15% vs 0%). recently, a randomized italian monocenter study showed a significant decrease in endoscopic recurrence rate at 6 and 18 months (22.2% versus 62.8% and 25% versus 67.4%), as well as a decrease in clinical recurrence. the limitations of this study are its monocentric nature and the lack of centralization of the endoscopic analysis to assess the primary endpoint. this surgical technique has been performed in some centers for ileocolonic crohn's surgery since 2020. nevertheless, the level of evidence remains too low to establish practice recommendations. the koala study will be the first prospective, multicenter, randomized study comparing kono-s anastomosis and conventional anastomosis for ileocolonicresection of crohn's disease, with blinded and centralized evaluation of recurrence.


Eligibility criteria:
inclusion criteria: * adult patient ≥ 18 years and ≤75 years * with crohn's disease. * requiring a first ileocolonic resection: fistulizing, abscessed, or stenosing disease or disease refractory to medical treatment. * affiliated to the french social security system. exclusion criteria: * previous ileocolonic resection * contraindication to postoperative endoscopy. * anastomosis with a planned defunctioning protective stoma. * emergency surgery (peritonitis). * lack of consent to the study. * pregnant patients. * refusal to participate or inability to provide informed consent. * patient under legal protection (individuals under guardianship by court order)

Keywords: crohn's disease kono-s anastomosis conventional anastomosis endoscopic recurrence
oculusgen (ologen) glaucoma mmc control in estonia

Conditions: Open Angle Glaucoma; Angle Closure Glaucoma; Uveitis Glaucoma; Young Age Glaucoma; Neovascular Glaucoma; High Risk Patient

Summary: to compare the safety and effectiveness between ologen collagen matrix and mitomycin-c (mmc) in glaucoma surgery. the ologen collagen matrix implantation procedure is same as traditional trabeculectomy except implant the ologen collagen matrix on the top of sclera flap after one loose stich the sclera flap. the mmc application is as the standard.

ologen collagen matrix is implanted on the top of sclera flap after the loose stich sclera flap is done for the filtering surgery. the concept of ologen collagen matrix is to creat the subconjunctiva bleb and modulate the wound healing for the surgery. by implanting ologen collagen matrix in the place, subconjuctival and trabdoor scars might be prevented. this is because the ologen collagen matrix is a 3-d scaffold porous structure that can guide fibroblast to grow randomly, instead of linear alignment. this can reduce the scar formation. doctors apply mmc for the glaucoma surgery is also trying to inhibite the scar formation. but mmc has been long time used and glaucoma specialists have not found anything to replace it. ologen collagen matrix concept is not inhibition, it is guiding and creating a physiological tissue. the successful of ologen collagen matrix may be on par with mmc but the safety and side effects will be much less.

Eligibility criteria:
inclusion criteria: * max anti glaucoma medication failed, exclusion criteria: * age less than 18, woman in pregnant, hemodialysis patient

Keywords: ologen oculusgen collagen matrix trabeculectomy filtering surgery mitomycin-c mmc aeon astron
"clinical and epidemiological characteristics of inflammatory rhinitis in patients on biotherapies"

Conditions: Inflammatory Rhinitis

Summary: inflammatory rhinitis is a side effect observed in patients treated with biotherapies in the context of chronic bowel disease (ibd) or spondylartrhopathy (spa). this damage is still poorly described in the literature. i the objective of this study is to study the associated characteristics of crustal rhinitis in a cohort of patients treated with biotherapy for chronic inflammatory disease (ibd, spa, psoriasis).

inflammatory rhinitis is a side effect observed in patients treated with biotherapies in the context of chronic bowel disease (ibd) or spondylartrhopathy (spa). this damage is still poorly described in the literature. it can occur in isolation or in association with a fold pustulose table, which differs from the classic fold pustulose described by cribier et al in autoimmune diseases by the presence of staphylococcus aureus in the pustules. some authors also describe associated paradoxical psoriasiform reactions or an impetigo. in our experience, this condition is more frequently found in patients treated for ibd or spa and has a clinically characteristic fissure appearance. thus, the semiology but also the epidemiology of this crusty rhinitis is still poorly described. the objective of this study is to study the associated characteristics of crustal rhinitis in a cohort of patients treated with biotherapy for chronic inflammatory disease (ibd, spa, psoriasis). patient recruitment will take place over a one-year period, in a multi-centre manner (angers and nantes university hospital) with prospective data collection in the form of a questionnaire and clinical evaluation during a dermatology consultation planned in the traditional care pathway for the follow-up of patients with skin manifestations during biotherapy treatment.

Eligibility criteria:
inclusion criteria: * adult patient (\> 18 years of age), * biotherapy treatment: anti tnf, ustekinumab, secukinumab, ixekizumab, rituximab, vedolizumab, abatacept, inhibitor jak kinase, anti il1, anti il6, * biotherapy treatment \> 3 months, * chronic inflammatory disease: psoriasis, ankylosing spondylitis (spa), rheumatoid arthritis (ra), crohn's disease (cd), bleeding rectocolitis (hrc) * no opposition to the study exclusion criteria: * patient under legal protection measure, * refusal of the subject to participate in the study,
carbon monoxide's headache inducing characteristics and effects on the cerebral arteries and blood flow

Conditions: Headache; Migraine

Summary: in this study the investigators will research the hypothesis that the gas carbon monoxide induces headache and increases the blood flow velocity in the middle cerebral artery.

to investigate headache score and accompanying symptoms during and after inhalation of carbon monoxide. with transcranial doppler imaging, c-scan and laser speckle the investigators will investigate changes in blood flow velocity of the middle cerebral artery (mca), diameter of the superficial temporal artery (sta), the radial artery and facial skin perfusion.

Eligibility criteria:
inclusion criteria: * healthy volunteers * aged 18-50 * 50-100 kg exclusion criteria: * tension type headache more than once/month * other primary headaches * daily medication except contraceptives * drug taken within 4 times the halflife for the specific drug except contraceptives * pregnant or lactating women * exposure to radiation within the last year * headache within the last 24 hours before start of trial * hypertension * hypotension * respiratory or cardiac disease * smoking * primary relatives with current or previous migraine

Keywords: carbon monoxide headache migraine
expressive helping for stem cell transplant patients

Conditions: Stem Cell Transplantation; Hematologic Malignancy

Summary: the writing for insight, strength, and ease (wise) study is a multisite randomized controlled trial (rct) testing the efficacy of the expressive helping (eh) intervention among adults receiving hematopoietic stem cell transplantation.

use of stem cell transplant (mostly for hematologic cancers) is expected to increase 5-fold by 2030, when the number of survivors will reach 500,000. this highly toxic treatment causes a range of acute physical and psychological symptoms, which then persist for years for up to 45% of patients. to address gaps in existing symptom-focused behavioral interventions that can be added to standard patient care, the investigators developed expressive helping (eh), a low-cost, low-burden intervention that targets a range of physical and psychological symptoms in a broad group of transplant recipients. eh is completed in 4 brief structured writing sessions during and immediately after transplant, with instructions focused on having participants write about their transplant experience. based on promising preliminary data, the investigators propose to determine whether eh can be used during and immediately after transplant to reduce common acute physical and psychological symptoms and prevent development of persistent physical and psychological symptoms. assessments of physical symptoms and psychological symptoms will occur at baseline (prior to randomization), "nadir" (day 7 post-transplant), "engraftment" (day 14 post-transplant), 1 week post-intervention, 3-months post-intervention (primary endpoint, early post-transplant), 6-months post-intervention, and 12-months post-intervention (primary endpoint, later post-transplant). the investigators will also assess a select set of potential mediators and moderators of intervention effects. participants will be adult cancer patients scheduled for allogeneic or autologous stem cell transplant at the study sites. after screening and consent, eligible patients will be enrolled in a parallel-group, 1:1 randomized controlled trial. randomization will be stratified by study site (jtcc, lombardi comprehensive cancer center, lccc, or robert h. lurie comprehensive cancer center, rhlccc); sex (linked with patient outcomes), age (18-59, ≥ 60), and transplant type (autologous, allogeneic). staff performing assessments will be blind to study assignment. participants cannot be blinded, but hypotheses will not be revealed to them until trial completion. they will be asked not to reveal their assignment to staff.

Eligibility criteria:
inclusion criteria: * cancer patients * age ≥ 18 * english proficient * scheduled for allogeneic or autologous transplant at jtcc, lccc, or rhlcc. exclusion criteria: * current participation in a behavioral intervention targeting symptoms or quality of life * cognitive or psychiatric impairment precluding ability to complete informed consent or study procedures * literacy limitations precluding completion of a writing study * undergoing a tandem transplant where participant is now completing the first of two or more planned transplants
educational interventions for surgeons during covid-19 pandemic: cross-sectional, e-survey

Conditions: COVID-19

Summary: the coronavirus disease 2019 (covid-19) pandemic required a rapid surge of healthcare capacity to face a growing number of critically ill patients. for this reason, a support reserve of physicians, including surgeons, were required to be reassigned to offer support. given the time shortage for trainers and trainees, time and cost-efficient programs to gain maximal benefit from short rotations for several physicians at one time are required 8. in case of pandemics, blending face-to-face education to e-learning seems sustainable, with online resources being scalable and more cost effective than other methods 9.

the aim of this study was to realize a survey on the educational programs (hospital based or web-based), during the covid-19 pandemic, and their impact on behavior change, satisfaction and knowledge of the target population of surgeons.

Eligibility criteria:
inclusion criteria: * residents, fellows, consultants and physicians of any grade and affiliated to any surgical specialty exclusion criteria: * mecical speciality

Keywords: 2019-ncov covid-19 pandemic educational intervention medical education